An Extension of the CONCERT Protocol (DIM18)

Phase 3

Terminated

• Conditions: Alzheimer's Disease
• Interventions: Drug: Dimebon

• Registration Number: NCT01152216
• Lead Sponsor: Medivation, Inc.

Brief Summary

An open-label extension study of the CONCERT (DIM18) protocol evaluating the safety of dimebon (latrepirdine) in subjects with With Mild-to-Moderate Alzheimer's Disease on Donepezil.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-06-25
• Study First Submitted QC: 2010-06-28
• Study First Posted: 2010-06-29
• Primary Completion: 2012-05
• Status Verified: 2016-09
• Disposition First Submitted: 2016-09-26
• Disposition First Submitted QC: 2016-09-26
• Last Update Submitted: 2016-09-26
• Disposition First Posted: 2016-09-27
• Last Update Posted: 2016-09-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 672

Inclusion Criteria

• Successful completion of the 12 month DIM18 CONCERT study
• Mild-to-moderate Alzheimer's disease
• Probable AD, Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revised (DSM-IV-TR)
• Mini-Mental State Exam (MMSE) score between 12 and 24, inclusive
• Stable on donepezil for at least 6 months

Exclusion Criteria

• Other causes of dementia
• Major structural brain disease
• Unstable medical condition or significant hepatic or renal disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dimebon	Dimebon	-

Primary Outcome Measures

Name	Time	Method
Safety	Through study discontinuation	To evaluate the long-term safety and tolerability of dimebon (latrepirdine) in Alzheimer's disease (AD) patients who have completed 52 weeks of blinded treatment in the DIM18 (CONCERT) protocol.